E6-7325. Support, Training and Capacity-Building for Infectious Disease Surveillance in the Republic of Panama and Other Countries in Central America

AGENCY:

Office of the Secretary, Office of Public Health Emergency Preparedness.

ACTION:

Notice.

Announcement Type: Single-Source, Cooperative Agreement.

Funding Opportunity Number: Not applicable.

Catalog of Federal Domestic Assistance Number: The Office of Management and Budget (OMB) Catalog of Federal Domestic Assistance number is pending.

SUMMARY:

This is a project to enhance the surveillance, epidemiological investigation, and laboratory diagnostic capabilities in Panama and other selected countries in Latin America that are at risk for an avian influenza (H5N1) outbreak. Such enhancements will help establish an early-warning system that could prevent and contain the spread of a highly pathogenic avian influenza to the United States and enhance our nation's preparedness for a possible human influenza pandemic.

DATES:

To receive consideration, applications must be received no later than 5 p.m. Eastern Time on June 29, 2006.

ADDRESSES:

Applications must be received by the Office of Grants Management, Office of Public Health and Science (OPHS), Department of Health and Human Services, 1101 Wootten Parkway, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Lily O. Engstrom, Senior Policy Advisor to the Assistant Secretary for Public Health Emergency Preparedness, Office of Public Health Emergency Preparedness, Department of Health and Human Services at 202.205.2882.

SUPPLEMENTARY INFORMATION:

In the last century, three influenza pandemics have struck the United States and the world, and viruses from birds contributed to all of them. In 1918, the first pandemic killed over 500,000 Americans and more than 20 million people worldwide. The pandemic of 1918 infected one-third of the U.S. population and reduced American life expectancy by 13 years. Following the 1918 outbreak, influenza pandemics in 1957 and 1968 killed tens of thousands of Americans and millions across the world. The recent limited outbreak of Severe Acute Respiratory Syndrome (SARS) suggests the danger that a modern pandemic would present.

The H5N1 strain of avian flu has become the most threatening influenza virus in the world, and any large-scale outbreak of this disease among humans would have grave consequences for global public health. Influenza experts have warned that the re-assortment of different H5N1 viruses over the past seven years greatly increases the potential for the viruses to be transmitted more easily from person to person. Medical practitioners have also discovered several other, new avian viruses that can be transmitted to humans.

The U.S. Government is concerned that a new influenza virus could become efficiently transmissible among humans. Now spreading through bird populations across Asia, Europe, the Middle East and, most recently, Africa, the H5N1 strain has infected domesticated birds such as ducks and chickens and long-range migratory birds. In 1997, the first recorded H5N1 outbreak in humans took place in Hong Kong. H5N1 struck again in late 2003 and has, as of May 5, 2006, resulted in 206 confirmed cases and 114 deaths in nine countries, a 55 percent mortality rate. As of now, the H5N1 avian flu is primarily an animal disease; H5N1 infection in humans has been the result of contact with sick poultry. Unless people come into direct, sustained contact with infected birds, it is unlikely they will contract the disease. The concern is that the virus will acquire the ability for sustained transmission among humans.

In the fight against avian and pandemic flu, early detection is the first line of defense. A pandemic is like a forest fire. If caught early, it might be extinguished with limited damage. But if left undetected, it can grow into an inferno that spreads quickly. The President has charged the Federal Government to take immediate steps to ensure early warning of an avian flu outbreak among animals and humans anywhere in the world. It is in the interest of the U.S. Government to help establish early-warning surveillance systems and laboratory capabilities in various regions of the world that would enable early detection, reporting, identification and investigation of any H5N1 outbreaks. The development of such capabilities could make a significant difference in preventing and containing the spread of an avian influenza pandemic to the United States.

On November 1, 2005, President Bush announced the National Strategy for Pandemic Influenza, and the following day Secretary of Health and Human Services, Michael O. Leavitt, released the HHS Pandemic Influenza Plan. The President directed all relevant Federal Departments and agencies to take steps to address the threat of avian and pandemic influenza. Drawing on the combined efforts of Government officials, the public health, medical, veterinary, and law-enforcement communities, as well as the private sector, this strategy is designed to meet three critical goals: Detecting human or animal outbreaks that occur anywhere in the world; protecting the American people by stockpiling vaccines and antiviral drugs, while improving the capacity to produce new vaccines; and preparing to respond at the Federal, State, and local levels in the event an avian or pandemic influenza reaches the United States. The U.S. National Strategy for Pandemic Influenza is available at http://www.pandemicflu.gov.

One of the primary objectives of both the National Strategy and the HHS Pandemic Influenza Plan is to leverage global partnerships to increase preparedness and response capabilities around the world (with the intent of stopping, slowing or otherwise limiting the spread of a pandemic to the United States.” ^[1] Pillars Two and Three of the National Strategy set out clear goals of ensuring the rapid reporting of outbreaks and containing such outbreaks beyond the borders of the United States, by taking the following actions:

• Working through the International Partnership on Avian and Pandemic Influenza, as well as through other political and diplomatic channels, to ensure transparency, scientific cooperation and rapid reporting of avian and human influenza cases;
• Supporting the development of the proper scientific and epidemiological expertise in affected regions to ensure early recognition of changes in the pattern of avian or human influenza outbreaks;
• Supporting the development and sustainment of sufficient host-country laboratory capacities and diagnostic reagents in affected regions, to provide rapid confirmation of cases of influenza in animals and humans;
• Working through the International Partnership to develop a coalition of strong partners to coordinate actions to limit the spread of an influenza virus with pandemic potential beyond the location where it is first detected; and
• Providing guidance to all levels of Government in affected nations on the range of options for infection-control and containment.

We rely upon our international partnerships with the United Nations (UN), international organizations, foreign governments and private non-profit organizations to amplify our efforts and will engage them on both a multilateral and bilateral basis. Our international effort to contain and mitigate the effects of an outbreak of pandemic influenza is a central component of our overall strategy. In many ways, the character and quality of the U.S. response and that of our international partners could play a determining role in the magnitude and severity of a pandemic.

The International Partnership on Avian and Pandemic Influenza, launched by President Bush at the UN General Assembly in September 2005, stands in support of multinational organizations and National Governments. Members of the Partnership have agreed that the following 10 principles will guide their efforts:

1. International cooperation to protect the lives and health of our people;

2. Timely and sustained, high-level, global political leadership to combat avian and pandemic influenza;

3. Transparency in reporting of influenza cases in humans and in animals caused by virus strains that have pandemic potential, to increase understanding and preparedness, especially to ensure rapid and timely response to potential outbreaks;

4. Immediate sharing of epidemiological data and samples with the World Health Organization (WHO) and the international community to detect and characterize the nature and evolution of any outbreaks as quickly as possible by utilizing, where appropriate, existing networks and mechanisms;

5. Rapid reaction to address the first signs of accelerated transmission of H5N1 and other highly pathogenic influenza strains so that appropriate international and national resources can be brought to bear;

6. Prevention and containment of an incipient epidemic through capacity-building and in-country collaboration with international partners;

7. Working in a manner complementary to and supportive of expanded cooperation with and appropriate support of key multilateral organizations (including the WHO, the UN Food and Agriculture Organization (FAO) and the World Organization for Animal Health [OIE]);

8. Timely coordination of bilateral and multilateral resource allocations; dedication of domestic resources (human and financial); improvements in public awareness; and development of economic and trade contingency plans;

9. Increased coordination and harmonization of preparedness, prevention, response and containment activities among nations, complementing domestic and regional preparedness initiatives and encouraging, where appropriate, the development of strategic regional initiatives; and

10. Actions taken based on the best available science.

Through the Partnership and other bilateral and multilateral initiatives, we will promote these principles and support the development of an international capacity to prepare, detect and respond to an influenza pandemic.

In support of the President's National Strategy and consistent with the principles of the International Partnership, the program funded by this cooperative agreement intends to combine the efforts and the resources of the Department of Health and Human Services (HHS) and those of other public and private organizations to enhance outbreak surveillance and investigation capacity in affected or at-risk regions of the world. For example, HHS will be collaborating with the Institut Pasteur and its network of research and surveillance institutes to detect, identify, report and investigate any H5N1 outbreaks in S.E. Asia and Africa. HHS intends, with this proposed cooperative agreement, to collaborate similarly with the Gorgas Memorial Institute for Health Studies (GMI) to enhance outbreak surveillance and investigation capacity in Panama and other countries in Central America.

To achieve enhanced laboratory capacity at GMI in support of influenza-like illness (ILI) surveillance, this cooperative agreement will fund the following:

• Costs connected with the shipment and testing of ILI surveillance samples from Panama and other countries in Central America;
• Costs for GMI to undertake surveillance for H5N1 avian influenza in Panama and other countries in Central America. This component of the agreement will include building field-investigation as well as laboratory capacity;
• Enhanced interoperable communications between GMI and HHS agencies, the WHO Secretariat and WHO Regional Office of the Americas/the Pan American Health Organization (PAHO);
• A portion of annual maintenance costs for the Biosafety-Level (BSL)-3 laboratory at GMI, once it is operational;
• Installation of appropriate enhancements of physical security at GMI to ensure that only authorized persons have access to the BSL-3 suite and to safeguard the equipment and collections of virus samples kept in the laboratory; and
• Support of a post-doctoral position for a well credentialed scientist in the GMI laboratory to focus exclusively on influenza surveillance in Panama and other countries in Central America.

No funds provided under this cooperative agreement may be used to support any activity that duplicates another activity supported by any component of HHS. Funds provided under this cooperative agreement may not be used to supplant funding provided by other sources. All funded activities must be coordinated with the Office of Public Health Emergency Preparedness (HHS), with the respective National Ministries of Health and, where feasible, with the Medical Entomology Research and Training Unit Guatemala (MERTU/G), a research unit of the HHS Centers for Disease Control and Prevention (CDC), and with the U.S. Naval Medical Research Unit (NAMRU-1) in Lima, Peru, a research unit of the U.S. Department of Defense.

I. Funding Opportunity Description

Authority: Sections 301, 307, 1701 and 2811 of the Public Health Service Act, 42 U.S.C. 241, 2421, 300u, 300hh-11.

Purpose: The purposes of the program are to accomplish the following:

• Enhance cooperation between the HHS and GMI to support and increase influenza outbreak investigation, surveillance, and training capacity in Panama and other countries in Central America;
• Enhance laboratory capacities for H5N1 diagnosis in GMI's Influenza-Like Illness (ILI) surveillance program;
• Enhance and expand GMI's capacity to conduct human and animal surveillance activities in Panama and other countries in Central America;
• Enhance and expand the training capacity for H5N1 avian influenza surveillance and epidemiology within Panama and other Central American countries, as well as provide and expand biosafety and biosecurity training for the BSL-3 facilities at GMI (once such facilities are completed);
• Enhance communications and interoperable connectivity between GMI, the WHO Secretariat, PAHO, HHS and its agencies; and
• Enhance security at the BSL-3 laboratory and related physical plant for GMI.

Measurable outcomes of the program will be in alignment with the President's National Strategy and the principles of the International Partnership on Avian and Pandemic Influenza, and one (or more) of the following performance goal(s) for the agency pursuant to the President's initiative on pandemic influenza preparedness:

• To detect animal and human outbreaks before they spread around the world;
• To take immediate steps to ensure early warning of an avian flu outbreak among animals or humans in affected regions; and
• To strengthen a new international partnership on avian influenza.

Grantee Activities

Grantee activities for this program are as follows:

• Enhance laboratory capacities for H5N1 diagnosis in GMI, based on the enhancement of diagnostic test sensitivity, on testing an increased number of in-country samples as well as samples from other countries in Central America;
• Enhance and expand training capacity for H5N1 surveillance and epidemiology in Panama and other countries in Central America;
• Support surveillance for influenza-like illness (ILI), severe pneumonia and other respiratory diseases, carried out through and/or on behalf of the respective Ministries of Health of Panama and other Central American countries;
• Strengthen the capacity for early detection and early warning of avian influenza outbreaks in Panama and other countries in Central America;
• Provide support (financial and technical) to systematic, extensive epidemiological and viral investigations following any confirmed H5N1 human or animal cases in Panama and other countries in Central America; and
• Where appropriate, coordinate activities conducted under this cooperative agreement with member institutes of the Reseau International des Instituts Pasteur in the Americas, with MERTU/G and with NAMRU-1.

GMI will share all influenza virus information obtained or developed as a result of the foregoing activities or other activities funded under this cooperative agreement with HHS, as well as within the WHO Global Influenza Network and WHO Collaborating Centers for Influenza. As part of its proposal, GMI shall submit a plan for ensuring the sharing of such information in a timely, accurate, thorough and reliable manner with HHS and the WHO. Such plan will also address the sharing with HHS of specimens and other viral material obtained by GMI as a result of activities funded under this cooperative agreement.

This cooperative agreement will provide limited and specific funding, as detailed below, for the following activities:

• Enhanced communications and interoperable connectivity between GMI and HHS agencies, as well as with the WHO Secretariat and PAHO.

The occurrence of A/H5N1 avian influenza outbreaks throughout S.E. Asia, Eastern and Western Europe and several countries on the African continent makes clear the swift spread of the virus to various regions of the world. Scientists and public health experts have predicted the arrival of the H5N1 virus in the Americas sometime this summer or fall. It is therefore essential that GMI have the capacity to communicate (by voice, data and video) with the WHO Secretariat, HHS (including both CDC and the National Institutes of Health [NIH]) and PAHO in real time and at high speed. This enhanced capability will enable the GMI laboratories to consult with scientific experts around the world and provide important disease surveillance data in a timely manner. Rapid advancements in the understanding of A/H5N1 and other emerging diseases are often heavily dependent on communications technology.

Funding for this activity, in the amount of $54,000, will support the purchase of hardware and software and the installation required to develop the interoperable connectivity. GMI will provide matching funds in the amount of $54,000 for the upgrading of Internet capabilities and creating a special room for communications equipment. This cooperative agreement will also support maintenance costs for three years, at $10,000 per year. GMI will also provide $10,000 per year for three years for maintenance costs (total of $30,000).

• Enhancements of laboratory capacity at GMI.

Once the BSL-3 facility is near completion, GMI will have to acquire various laboratory equipment to conduct the type of research and sample testing that require this level of biosecurity. This enhanced laboratory capacity will greatly facilitate the identification of H5N1 in humans and animals as well as other viruses responsible for other infectious, respiratory diseases.

This cooperative agreement will fund laboratory equipment in the amount of $485,000 for the first year and $100,000 for the second year. GMI will provide cost-sharing in the amount of $100,000 for the first year only.

• Security enhancements to BSL-3 laboratory and related physical plant for GMI.

A BSL-3 laboratory at GMI will substantially enhance capacity in Panama and Central America to isolate and work with the A/H5N1 virus and other emerging infectious diseases. It is essential that the physical security (including biosecurity and entry-control systems) for the BSL-3 facility be sufficient to ensure the integrity of the laboratory and prevent unauthorized access.

This cooperative agreement will provide one-time funding in the amount of $50,000 for the first year for costs associated with acquiring and installing entry-control systems and other physical-security enhancements (including vehicular barriers, cameras, monitors and locking devices) for the BSL-3 facility. GMI will provide matching funds in the amount of $50,000 for a back-up power plant.

• Support for an international biosafety/biosecurity technical advisor/consultant for the new BSL-3 laboratory suite at GMI.

Since BSL-3 biosafety/biosecurity practices are complicated and require 100 percent compliance at all times that the laboratory is operational, it is essential that GMI and its employees have access to an international technical advisor/consultant with substantial biosafety/biosecurity experience. This will ensure the safe and efficient operation of the laboratory and provide critically important on-the-job training to GMI scientists and technicians who work in the BSL-3 facility.

This cooperative agreement will provide funding in the amount of $50,000 per year for three years.

• Human and animal influenza surveillance capacity-building in Panama and other countries in Central America. A/H5N1 is an avian disease, which makes animal sampling essential to any meaningful surveillance program. GMI has established working relationships with the appropriate health and agriculture authorities in various Central American countries. Coupled with its resources and technical capabilities, GMI is, therefore, uniquely qualified to undertake animal and human H5N1 surveillance in these countries, especially upon completion of its BSL-3 laboratory.

Funding for animal and human ILI surveillance capacity building will be $125,000 for the first year and $250,000 for each of the following two years. GMI will cost-share by paying for laboratory and field epidemiology technicians, reagents, supplies and transport.

• Enhancement of capacity for training personnel in influenza (particularly H5N1) and ILI surveillance, diagnostics and epidemiological investigations in Panama and other Central American countries.

GMI is also an important training asset in the region and can leverage existing and new programs to maximize training opportunities. To ensure that there are sufficient numbers of trained personnel to carry out the surveillance, diagnosis and outbreak investigations of influenza, especially H5N1, and ILI illnesses, GMI must provide training in virology laboratory procedures and epidemiological investigations to include not only personnel in Panama but also trainees from other countries in Central America (and, if feasible, Colombia and other Andean countries).

Total funding for training of Panamanian nationals will be $125,000 for three years ($25,000 in the first year; $50,000 for each of the following two years). Training of nationals from other Central American countries will be $200,000 per year for the second and third year of the project.

• In order to ensure that the GMI Laboratory will adequately support a number of the activities undertaken pursuant to this cooperative agreement, some additional research capacity is required to increase the laboratory's capability to respond in a timely manner to developments in the field. In this regard, GMI will recruit and fill a post-doctoral position with a scientist who will have responsibilities in influenza research.

Funding for this activity will be $30,000 per year for the second and third year of the project. GMI will be providing $30,000 in matching funds and seeking $30,000 in matching funds from the Panamanian Science and Technology Secretariat.

HHS, particularly the Office of Public Health Emergency Preparedness, will be substantially involved with the design and implementation of the described grantee activities. HHS staff activities for this program are as follows:

• Provide expert assistance in the design, implementation and delivery of instruction to individuals selected for epidemiology training and laboratory-support training;
• Provide liaison through HHS employees at U.S. Embassies in host countries with local Ministries of Health and Agriculture and other host-nation organizations, as appropriate, and as relevant to the achievement of the purposes of this cooperative agreement; and
• Provide oversight of activities supported by funds awarded through this cooperative agreement.

II. Award Information

This project will be supported through the cooperative agreement mechanism. OPHEP anticipates making only one award. The anticipated start date is approximately August 1, 2006, and the anticipated period of performance is approximately August 1, 2006, through July 31, 2009.

OPHEP anticipates that approximately $775,000 will be available for the first 12-month budget period. The total amount that the Gorgas Memorial Institute for Health Studies may request is $2,079,000 for three years. The funds in this cooperative agreement will not support indirect costs.

Approximate Current Fiscal Year Funding: $775,000.00.

Approximate Total Project Period Funding: $2,079,000.00.

Funds under this cooperative agreement shall not apply to indirect costs.

Funding Breakdown:

Activity	Current year funding	Year 2 funding	Year 3 funding	Total funding per activity
Enhanced communications (matching funds)	$30,000	$12,000	$12,000	$54,000
Maintenance of communications systems (matching funds)	10,000	10,000	10,000	30,000
Surveillance of H5N1 avian influenza, ILI, and severe pneumonia in humans and animals (cost-sharing with HHS)	125,000	250,000	250,000	625,000
Enhancement of laboratory capacity at GMI (cost-sharing with HHS in Year 1 only)	485,000	100,000		585,000
Virology laboratory and outbreak investigation training	25,000	250,000	250,000	525,000
Security and biosecurity enhancements (matching funds)	50,000			50,000
International biosafety/biosecurity technical advisor/consultant	50,000	50,000	50,000	150,000
Post-doctoral position (matching funds)		30,000	30,000	60,000
Grand Total	775,000	702,000	602,000	2,079,000

Approximate Number of Awards: 1.

Ceiling of Individual Award Range: Maximum dollar amount for the first 12-month budget period is $775,000, and will not include payment of any indirect costs.

Throughout the project period, the commitment of HHS to the continuation of funding will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), demonstrated commitment of the recipient to the principles of the International Partnership on Avian and Pandemic Influenza, and the determination that continued funding is in the best interest of the Federal Government and continues to meet the goals of the U.S. National Strategy for Pandemic Influenza.

III. Eligibility Information

1. Eligible Applicants

The only eligible applicant that can apply for this funding opportunity is the Gorgas Memorial Institute for Health Studies of Panama. The Republic of Panama has legacy of biomedical triumphs that began with the building of the Panama Canal. Recognizing the outstanding achievements of William Crawford Gorgas in eliminating Yellow Fever and controlling other tropical infections that made possible the construction of the Panama Canal, Panamanian President Belisario Porras proposed in 1920, the creation of the Gorgas Memorial Institute and Laboratories (GMI). GMI opened its doors in 1928, and since then has produced groundbreaking and internationally recognized work in the field of tropical medicine, emerging and re-emerging diseases.

As a public health organization and a research institution, GMI offers strengths in several areas that are essential to early detection, reporting, identification and investigation of human and animal influenzas, including H5N1.

• Laboratory: It has well-established laboratories of virology, parasitology, immunology, genomics, entomology and food and water chemistry. GMI is the national reference laboratory for malaria, tuberculosis and all viral and bacterial diseases. GMI also has departments of epidemiology and biostatistics, chronic disease studies, health policy, and health and human reproduction studies. In addition to all these areas of expertise, GMI is also the locus of the national human subjects committee (National Institutional Review Board). A BLS-3 laboratory currently under construction is part of a modernization plan that will significantly enhance the capability of GMI laboratories to work with highly pathogenic organisms, such as the more virulent strains of the H5N1 virus.
• Scientific and technical expertise: GMI is the national reference for influenza, dengue and other pathogenic viruses. It is the reference laboratory for Central America and Panama for HIV/AIDS, measles, Hanta virus and viral encephalitides. Its parasitologists have worked continue to work in malaria, leishmania and Chagas' disease. GMI has a long and solid reputation in virology, easily confirmed by many distinguished virologists in the United States. The Gorgas Department of Virology has been extremely productive through its collaborations with the Yale University Arbovirus Research Unit, the University of Texas at Galveston and the CDC. GMI began working with influenza in 1976 and has contributed influenza isolates to the WHO, one of which is used in the current influenza vaccines.
• Staffing: GMI has 178 workers that include scientists, physicians, technical staff and administrative staff. GMI scientific and technical expertise resides in its excellent group of professionals, six of whom are Ph.D.s and eleven of whom are M.D.s. One of the physicians is a former Minister of Health. GMI has two veterinary physicians, and many technicians with master degrees in science. GMI has a specialist in georeference and a group trained in field isolation of dangerous organisms from animal tissues (developed during the Hanta virus epidemics). There is also an excellent administrative, medical library and informatics staff.

In addition to the factors described above, there are several others that make GMI such a choice partner in Central America for collaboration on H5N1 surveillance.

1. Human Travel Through Panama

The unique geographic characteristics of Panama and its transportation (air, sea and land) infrastructure make it an obligatory pass-through point for millions of travelers. Panama serves as the hub of the Americas for air travel, cargo transport and ship transits through the Panama Canal. It is also the land bridge for truck and bus transport of merchandise and travelers between South, Central and North America. Ten flights depart daily from Panama to different destinations in the United States, and many more to Mexico and countries in Central and South America. Every day, 40 ships cross the Panama Canal, and many more unload passengers and containers in Panamanian ports. Every day more than one hundred trucks and cars cross the Panama-Costa Rica border to transport passengers and cargo to destinations in Central and North America. These activities place Panama in a unique and important position to conduct surveillance of infectious diseases brought in by travelers and cargo, and to carry out epidemiological investigations of cases that emerge.

2. Bird and Animal Travel Through Panama

For the last three million years, Panama has served as a land bridge for migratory birds and a point for the exchange of land species between North and South America. Out of more than the approximately 600+ bird species in the Americas, more than 200 use Panama as a bridge for transit to South America and back to North America as part of their yearly migratory flights. Panama is the narrowest point of land in migratory flight patterns, which also make it a strategic point for the study of avian influenza and its movement in the Americas.

3. Strategic Partnerships

GMI has developed very close relations with the Smithsonian Tropical Research Institute (STRI) in Panama. STRI is the premiere research institution in the world dedicated to the investigation of the biology of the tropics. Scientists at GMI and STRI work on collaborative projects, and their respective directors meet regularly to discuss matters of common scientific interest. STRI has expressed significant interest in studying avian influenza in migratory birds and its impact on other resident and migratory species. GMI recently had conversations that led to the development of formal relations with the U.S. Department of Agriculture (USDA) in Panama. As a first step in this relationship, USDA requested and GMI agreed to train technicians in viral culture and isolation. The USDA will open a BLS-3 facility in Panama dedicated to the testing of commercial animals in the region, and GMI will collaborate in this effort. Gorgas, as a regional reference laboratory for HIV/AIDS, is in the process of developing a formal relationship with HHS/CDC-MERTU in Guatemala, and plans to explore the potential for developing a joint regional influenza surveillance program.

4. Historical Medical Collaboration Between the United States and Panama via GMI

American and Panamanian physicians and scientist have produced significant contributions since 1928, and those relationships continue up to present. This new relation will strengthen the concept of “forward sentinel laboratories” to detect pandemic and emerging diseases. It will also strengthen the positive image of the United States in the region.

2. Cost-Sharing or Matching Funds

Matching funds are required for this project. HHS will pay $2,079,000 or 88 percent of the total costs of $2,373,000 while GMI will provide $294,000 or 12 percent of total costs. Furthermore, GMI will also cost-share in expenses related to the surveillance of H5N1 virus, ILI and severe pneumonia in humans and animals by paying for laboratory and field epidemiology technicians, reagents, supplies and transport.

3. Other

If an applicant requests a funding amount greater than the ceiling of the award range, HHS will consider the application non-responsive, and the application will not enter into the review process. HHS will notify the applicant that the application did not meet the submission requirements.

Special Requirements

If the application is incomplete or non-responsive to the special requirements listed in this section, the application will not enter into the review process. HHS will notify the applicant that the application did not meet submission requirements.

• HHS will consider late applications non-responsive. Please see section on “Submission Dates and Times.”
• Title 2 of the United States Code section 1611 states that “an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.”

IV. Application and Submission Information

1. Address To Request Application Package

Application kits may be requested by calling [phone] or writing to the Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20852. Applicants may also fax a written request to the OPHS Office of Grants Management at [phone] to obtain a hard copy of the application kit. Applications must be prepared using Form OPHS-1.

2. Content and Form of Submission

Application: Applicants must submit a project narrative in English, along with the application forms, in the following format:

• If possible, the length of the proposal should not exceed 50 pages;
• Font size: 12-point, unreduced;
• Single-spaced;
• Paper size: 8.5 by 11 inches;
• Page-margin size: One inch;
• Number all pages of the application sequentially from page one (Application Face Page) to the end of the application, including charts, figures, tables, and appendices;
• Print only on one side of page; and
• Hold application together only by rubber bands or metal clips, and do not bind it in any way.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

• Understanding of the requirements. The application shall include a discussion of your organization's understanding of the need, purpose and requirements of this cooperative agreement, as well as the President's National Strategy and the principles of the International Partnership on Avian and Pandemic Influenza. The discussion shall be sufficiently specific, detailed and complete to clearly and fully demonstrate that the applicant has a thorough understanding of all the technical requirements of this announcement.
• A Project Plan. The project plan must demonstrate that the organization has the technical expertise to carry out the work/task requirements of this announcement. The plan must contain sufficient detail to clearly describe the proposed means for conducting the “Grantee Activities” described in Section I, and shall include a complete explanation of the methods and procedures the applicant will use. The project plan shall include discussions of the following elements:

◦ Objectives;

◦ Methods to accomplish the purposes of the cooperative agreement and the “Grantee Activities”;

◦ Detailed time line for accomplishment of each activity;

◦ Ability to respond to emergencies;

◦ Ability to respond to situations on weekends and after hours; and

◦ Coordination with HHS, the WHO Secretariat, PAHO, the FAO, and the OIE.

• Staffing and Management Plan. The applicant must provide a project staffing and management plan, which must include time lines and sufficient detail to ensure that it can meet the Federal Government's requirements in a timely and efficient manner.

◦ The applicant must provide resumes that identify the educational and experience level of any individual(s) who will perform in a key position and other qualifications to show the key individuals' ability to comply with the minimum requirements of this announcement;

◦ The applicant must provide a summary of the qualifications of non-key personnel. Resumes must be limited to three pages per person; and

◦ The proposed staffing plan must demonstrate the applicant's ability to recruit/retain/replace personnel who have the knowledge, experience, local-language skills, training and technical expertise commensurate with the requirements of this announcement. The plan must demonstrate the applicant's ability to provide bi-lingual personnel to train and mentor host-country participants.

• Performance Measures. The applicant must provide measures of effectiveness that will demonstrate accomplishment of the objectives of this cooperative agreement and progress toward the goals of the President's National Strategy. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcomes. The applicant must submit a section on measures of effectiveness with its application, and they will be an element for evaluation. In addition, the applicant shall insert the following as measures of applicant's performance:

◦ Number of new epidemiologists actually trained and employed from each designated country;

◦ Number of new laboratorians actually trained in virologic techniques and employed in each designated country;

◦ Whether GMI establishes formal and reliable communication links with the WHO Global Outbreak Alert and Response Network (GOARN), the WHO Global Influenza Surveillance Network, and the equivalent animal-disease surveillance networks at the FAO and OIE;

◦ The number, accuracy, thoroughness and timeliness of reports to the WHO Global Influenza Surveillance Network from GMI;

◦ The number, accuracy, thoroughness, and timeliness of other notifications submitted to the WHO Secretariat and HHS regarding potential or actual outbreaks of ILI or other respiratory diseases in other countries in Central America; and

◦ The timely and successful appointment of a candidate for the post-doctoral position funded under this agreement.

• Budget Justification. The budget justification must comply with the criteria for applications. The applicant must submit, at a minimum, a cost proposal fully supported by information adequate to establish the reasonableness of the proposed amount.

The applicant may include additional information in the application appendices, which will not count toward the narrative page limit. This additional information includes the following:

• Curricula Vitae, Resumes, Organizational Charts, Letters of Support, etc.

An agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com,, or call 1-866-705-5711.

Additional requirements that could require submission of additional documentation with the application appear in section VI.2. Administrative and National Policy Requirements.

3. Submission Dates and Times

To be considered for review, applications must be received by the Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services by 5 p.m. Eastern Time on June 29, 2006. Applications will be considered as meeting the deadline if they are received on or before the deadline date. The application due date in this announcement supercedes the instructions in the OPHS-1.

Submission Mechanisms

The Office of Public Health and Science (OPHS), which is serving as the awarding agency for the Office of Public Health Emergency Preparedness, provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines identified below will not be accepted for review. Applications which do not conform to the requirements of the cooperative agreement announcement will not be accepted for review and will be returned to the applicant.

Applications may be submitted electronically only via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the OPHS eGrants system or the http://www.Grants.gov Web Site Portal is encouraged.

Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the “Submission Dates and Times” section of this announcement using one of the electronic submission mechanisms specified below. All required hard copy original signatures and mail-in items must be received by the OPHS Office of Grants Management no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the “Submission Dates and Times” section of this announcement.

Applications will not be considered valid until all electronic application components, hard copy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible.

The applicant is encouraged to initiate electronic applications early in the application development process, and to submit prior to or early on the due date. This will allow sufficient time to address any problems with electronic submissions prior to the application deadline.

Electronic Submissions via the OPHS eGrants System

The OPHS electronic grants management system, eGrants, provides for applications to be submitted electronically. Information about this system is available on the OPHS eGrants Web site, https://egrants.osophs.dhhs.gov,, or may be requested from the OPHS Office of Grants Management at [phone].

When submitting applications via the OPHS eGrants system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms (e.g., Program Certifications) with the original signature of an individual authorized to act for the applicant agency.

Electronic applications submitted via the OPHS eGrants system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however, these mail-in items must be entered on the eGrants Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation.

Upon completion of a successful electronic application submission, the OPHS eGrants system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission, including all electronic application components, required hard copy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted.

As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of its application in the OPHS eGrants system to ensure that all signatures and mail-in items are received.

Electronic Submissions via the www.Grants.gov Web Site Portal

The Grants.gov Web Site Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, http://www.grants.gov.

In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the cooperative agreement announcement as well as the application guidance provided within the Grants.gov application package to determine such requirements. Any required hard copy materials or documents that require a signature must be submitted separately via mail to the OPHS Office of Grants Management and, if required, must contain the original signature of an individual authorized to act for the applicant agency and to assume the obligations imposed by the terms and conditions of the cooperative agreement award.

Electronic applications submitted via the Grants.gov Web Site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. All required mail-in items must received by the due date specified above. Mail-In items may only include publications, resumes or organizational documentation.

Upon completion of a successful electronic application submission via the Grants.gov Web Site Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation as well as a copy of the entire application package for its records.

All applications submitted via the Grants.gov Web Site Portal will be validated by Grants.gov. Any applications deemed “Invalid” by the Grants.gov Web Site Portal will not be transferred to the OPHS eGrants system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Web Site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Web Site Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard copy materials.

Once the application is validated by Grants.gov, it will be electronically transferred to the OPHS eGrants system for processing. Upon receipt of both the electronic application from the Grants.gov Web Site Portal, and the required hard copy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Web Site Portal.

Applicants should contact Grants.gov regarding any questions or concerns about the electronic application process used by the Grants.gov Web Site Portal.

Mailed or Hand-Delivered Hard Copy Applications

Applicants who submit applications in hard copy (via mail or hand-delivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award.

Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the “Submission Dates and Times” section of this announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS-1. Applications that do not meet the deadline will be returned to the applicant unread.

4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

Restrictions, which applicants must take into account while preparing the budget, are as follows:

• Alterations and renovations (A&R) are prohibited under grants/cooperative agreements to foreign recipients. “Alterations and renovations” are defined as work that changes the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it can be used more effectively for its currently designated purpose or adapted to an alternative use to meet a programmatic requirement. Recipients may not use funds for A&R (including modernization, remodeling, or improvement) of an existing building.
• Recipients may not use funds for planning, organizing or convening conferences.
• Reimbursement of pre-award costs is not allowed.
• Recipients may spend funds for reasonable program purposes, including personnel, travel, supplies, and services. Recipients may purchase equipment if deemed necessary to accomplish program objectives; however, they must request prior approval in writing from HHS/OPHEP officials for any equipment whose purchase price exceeds $10,000 USD.
• The costs generally allowable in grants/cooperative agreements to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the WHO Secretariat, HHS will not pay indirect costs (either directly or through sub-award) to organizations located outside the territorial limits of the United States, or to international organizations, regardless of their location.
• Recipients may contract with other organizations under this program; however, the applicant must perform a substantial portion of the project activities (including program management and operations) for which it is requesting funds. Contracts will require prior approval in writing from HHS/OPHEP.
• Recipients may not use funds awarded under this cooperative agreement to support any activity that duplicates another activity supported by any component of HHS.
• Applicants shall state all requests for funds in the budget in U.S. dollars. Once HHS makes an award, HHS will not compensate foreign recipients for currency-exchange fluctuations through the issuance of supplemental awards.
• The funding recipient must obtain annual audits of these funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS.
• A fiscal Recipient Capability Assessment may be required, prior to or post award, to review the applicant(s business management and fiscal capabilities regarding the handling of U.S. Federal funds.

6. Other Submission Requirements

None.

V. Application Review Information

1. Criteria

HHS will evaluate applications against the following factors:

Factor 1: Project Plan (35 Points)

HHS will evaluate the extent to which the proposal demonstrates that the organization has the technical expertise to carry out the work/task requirements described in this announcement. HHS will evaluate the applicant's project plan to determine the extent to which it provides a clear, logical and feasible technical approach to meeting the goals of this announcement in terms of workflow, resources, communications and reporting requirements for accomplishing work in each of the operational task areas, which HHS will evaluate as equally weighted sub-factors, as follows:

• Design and implementation of a recruitment program that identifies potential participants for training in epidemiology and laboratory procedures with specific focus on influenza and other acute respiratory infections;
• Work with HHS to design and implement a process that identifies local individuals who have experience, training or education relevant to conducting epidemiological surveys or laboratory procedures, recruits those individuals to participate in training, and creates a pool of highly qualified candidates for positions within the host-country Ministries of Health or Agriculture;
• Design and implement a training program that assigns selected participants to work under the tutelage of senior GMI scientists in support of ILI research, disease surveillance and public health activities;
• Train a minimum of one local person in epidemiology each year in Panama and three in other Central American countries (a minimum of four), and a minimum of one local person as a laboratorian skilled in influenza diagnostics each year in Panama and three in other Central American countries (a minimum of four); and
• Provide real-time notification of possible outbreaks of influenza and ILI in humans or animals, and submit notification to HHS, the WHO Secretariat, PAHO, the FAO, and the OIE.

Factor 2: Staffing and Management Plan (30 Points)

(a) Personnel. HHS will evaluate the relevant educational, work experience and local-language qualifications of key personnel, senior project staff, and subject-matter specialists to determine the extent to which they meet the requirements listed in this announcement.

(b) Staffing Plan. HHS will evaluate the staffing plan to determine the extent to which the applicants proposed organizational chart reflects proper staffing to accomplish the work described in this announcement, and the extent of the applicants ability to recruit/retain/replace personnel who have the knowledge, experience, local-language skills, training and technical expertise to meet requirements of the positions.

Factor 3: Performance Measures (20 Points)

HHS will evaluate the applicant's description of performance measures, including measures of effectiveness, to determine the extent to which the applicant proposes objective and quantitative measures that relate to the performance goals stated in the “Purpose” section of this announcement, including the goals of the President's National Strategy, and whether the proposed measures will accurately measure the intended outcomes.

Factor 4: Understanding of the Requirements (15 Points)

HHS will evaluate the extent of the applicant's understanding of the operational tasks identified in this announcement to ensure successful performance of the work in this project. Because the focus of the work will be on countries in Central America, the applicant must demonstrate an understanding of the cultural, ethnic, political and economic factors that could affect successful implementation of this cooperative agreement.

The applicant's proposal must also demonstrate understanding of the functions, capabilities and operating procedures of host-country Ministries of Health and Agriculture and international organizations such as the WHO and FAO, and describe the applicant's ability to work with and within those organizations. The applicant must also demonstrate an understanding of the U.S. National Strategy for Pandemic Influenza and a commitment to the principles of the International Partnership on Avian and Pandemic Influenza.

2. Review and Selection Process

HHS/OPHEP will review applications for completeness. An incomplete application or an application that is non-responsive to the eligibility criteria will not advance through the review process. HHS will notify applicants if their applications did not meet submission requirements.

An objective review panel, which could include both Federal employees and non-Federal members, will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.

VI. Award Administration Information

1. Award Notices

The successful applicant will receive a Notice of Award (NoA). The NoA shall be the only binding, authorizing document between the recipient and HHS. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

2. Administrative and National Policy Requirements

A successful applicant must comply with the administrative requirements outlined in 45 CFR part 74 and part 92 as appropriate. The Fiscal Year 2006 Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, the issuance shall clearly state the percentage and dollar amount of the total costs of the program or project to be financed with Federal money and the percentage and dollar amount of the total costs of the project or program to be financed by non-governmental sources.

3. Reporting Requirements

The applicant must provide HHS with an original, plus two hard copies, as well as an electronic copy of the following reports in English:

1. A quarterly progress report, due no less than 30 days after the end of each quarter of the budget period. The progress report for the third quarter of the year will serve as the non-competing continuation application. The quarterly progress report must contain the following elements:

a. Activities and Objectives for the Current Budget Period;

b. Financial Progress for the Current Budget Period;

c. Proposed Activity Objectives for the New Budget Period;

d. Budget;

e. Measures of Effectiveness; and

f. Additional Requested Information.

2. An annual progress report, due 90 days after the end of the budget period, which must contain a detailed summary of the elements required in the quarterly progress report;

3. Final performance reports, due no more than 90 days after the end of the project period; and

4. A Financial Status Report (FSR) SF-269 is due 90 days after the close of each 12-month budget period.

Recipients must mail the reports to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

For program technical assistance, contact: Lily O. Engstrom, Senior Policy Advisor to the Assistant Secretary for Public Health Emergency Preparedness, Office of Public Health Emergency Preparedness, Department of Health and Human Services. Telephone: [phone]. E-mail: [e-mail].

For financial, grants management, or budget assistance, contact: Grants Management Specialist, Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20857. Telephone: [phone]. E-Mail Address: [e-mail].

Dated: May 9, 2006.

Stewart Simonson,

Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services.

Footnotes

1.  National Strategy for Pandemic Influenza, p. 2.